POMA Analysis
Act 96 of October 24, 2018
February 2019
Andy Sandusky 

Act 96 of October 24, 2018
Act 96 amends the state Controlled Substance, Drug, Device and Cosmetic Act to mandate scripts for classifications of scheduled drugs II-V be dispensed using electronic prescribing systems exclusively, with some exceptions.

Exceptions 
The electronic prescription requirement shall not apply if the prescription is issued:
(1)  by a veterinarian;
(2)  under circumstances when an electronic prescription is not available due to a temporary technological or electrical failure;
(3)  by a practitioner and dispensed by a pharmacy located outside this Commonwealth;
(4)  by a practitioner who or health care facility that does not have either of the following:
(i)  Internet access; or
(ii)  an electronic health record system;
(5)  by a practitioner treating a patient in an emergency department or a health care facility under circumstances when the practitioner reasonably determines that electronically prescribing a controlled substance would be impractical for the patient to obtain the controlled substance prescribed by electronic prescription or would cause an untimely delay resulting in an adverse impact on the patient's medical condition;
(6)  for a patient enrolled in a hospice program or for a patient residing in a nursing home or residential health care facility;
(7)  for controlled substance compounded prescriptions and prescriptions containing certain elements required by the Federal Food and Drug Administration or any other governmental agency that are not able to be accomplished with electronic prescribing;
(8)  for a prescription issued pursuant to an established and valid collaborative practice agreement between a practitioner and a pharmacist, a standing order or a drug research protocol;
(9)  for a prescription issued in an emergency situation pursuant to Federal or State law and regulations of the board;
(10)  under circumstances where the pharmacy that receives the prescription is not set up to process electronic prescriptions; or
(11)  for controlled substances that are not required to be reported to the Prescription Drug Monitoring Program system administered by the department.

Petitions for Additional Exceptions 
Petitions for additional exceptions may be granted by the Department of Health based upon economic hardship, technical limitations, or exceptional circumstances. The Department of Health can also grant additional exceptions not listed for in the Act, but must promulgate regulations to permit them. Additionally, the Department is required to adopt rules establishing the form for specific information to be included in a request for exemption.  

The Department of Health may approve an exemption for a period not to exceed one year and may be renewed annually upon request. 

Penalties 
A violation under the Act is a penalty of $100 for 1-10 violations; $250 for each additional violation capped at $5,000.

Effective Dates  
The effective date of the act is one year from the effective date, October 24, 2018 and the Department of Health is required to promulgate regulations within 6 months of the effective date.